Abstract
The development of drugs in the generic pharmaceutical industry is a highly competitive arena of companies vying for few drug products that are coming off patent. Companies that have been successful in this arena are those that have met or surpassed the critical timeline associated with trial formulation development, analytical method development, and submission batch manufacturing and testing. Barr Laboratories Inc., has been successful in the generic pharmaceutical industry for several reasons, one of which includes automation. The analytical research and development at Barr has employed the use of automated dissolution early in the lifecycle of a potential product. This approach has dramatically reduced the ‘time to market’ on average for a number of products. The key to this approach is the network infrastructure of the formulation and analytical research and development departments. At Barr, the cooperative ability to work and communicate together has driven the departments to streamline and matrix their work efforts and optimize resources and time. The discussion will reference how Barr has been successful with automation and gives a case study of products that have moved with rapid pace through the development cycle
Highlights
Barr Laboratories, Inc., has been a competitive player in the manufacture of generic pharmaceuticals as well as proprietary products
The development of drugs in the generic pharmaceutical industry is a highly competitive arena of companies vying for few drug products that are coming o¡ patent
Companies that have been successful in this arena are those that have met or surpassed the critical timeline associated with trial formulation development, analytical method development, and submission batch manufacturing and testing
Summary
Barr Laboratories, Inc., has been a competitive player in the manufacture of generic pharmaceuticals as well as proprietary products. One of the pillars of success has been the cooperative eå ort of the product development and analytical development teams. Companies who have been successful in the marketplace are those who have seized an opportunity for a viable product candidate, and been able quickly to expedite the development of that product and submit for approval. In the race for generic pharmaceuticals, there is no second place. Companies who come in second risk low market share for their product and, very little pro® t margin, if any. The critical success factor becomes the speed in which a biobatch formulation can be manufactured, the analytical method developed and validated, and the biobatch or clinical batch tested and submitted to the agency. { This paper was initially presented at the ISLAR 2000 Conference and is reproduced here by kind permission of Zymark Corporation
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
